Final Research Report

View this project's final research report.

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Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

  • Elaborating on the representativeness of the stakeholders who participated in the early development of the study. In responding to reviewer concerns that these stakeholders represented successful left ventricular assistive device (LVAD) treatment, the researchers added descriptions of the adverse events experienced by two of the stakeholders and pointed out that in their first aim, they completed in-depth interviews with 10 patients who had declined LVAD treatment. These perspectives were included in the risks section of the decision aid.
  • Explaining that the report’s description of a lack of bias in the decision aid was based on the observation that patients who received the decision aid did not make systematically different decisions than those who did not receive it. The reviewers were not clear that this observation reflected a lack of bias.
  • Confirming that although they were not able to achieve their originally planned sample size of 144 patients, the study was sufficiently powered with the actual sample size of 105 patients.
  • Noting that the researchers did not consider whether materials given to patients in routine clinical care overlapped or contradicted the material in the decision aid. Such materials would be clinic-specific and might therefore contribute to unmeasured differences among clinics.
  • Adding a description of plans for evaluating and updating the decision aid, since technology and clinical care for LVAD patients is rapidly advancing.

Conflict of Interest Disclosures

Project Information

Jennifer Blumenthal-Barby, MA, PhD
Baylor College of Medicine
$1,366,217
10.25302/4.2019.CDR.130601769
Development and User Testing of a Decision Aid for Ventricular Assist Device Placement

Key Dates

December 2013
June 2018
2013
2018

Study Registration Information

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Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
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Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: March 4, 2022